In-Person Lifestyle Program for Black Adolescent Girls at Risk for Type 2 Diabetes
- Conditions
- Diabetes Mellitus, Type 2Diabetes MellitusChildhood ObesityPediatric ObesityGlucose Metabolism DisordersOvernutritionOverweightBody WeightBehavior, AdolescentMetabolic Disease
- Registration Number
- NCT06557317
- Lead Sponsor
- Cornell University
- Brief Summary
The aim of this study is to look at changes in diabetes-related risk factors in Black adolescent girls who are at risk for type 2 diabetes and their primary female caregiver after both participating in a 12-week in-person lifestyle program.
- Detailed Description
Enrolled adolescent/caregiver dyads will participate in the 12-week program. Each week, participants will engage in 2 activities: an in-person Wellness Session and an at-home cooking experience using ingredients provided at the Wellness Session.
The study will examine the pre-post difference in overall diet quality, dermal carotenoid levels, physical activity, body composition, and glycemic measures among at-risk black adolescent girls and their caregivers. Investigators hypothesize that after the program, participants' diets will be higher in quality than before.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Change in diet quality of adolescent participants, as measured by the Healthy Eating Index Scores Baseline, 12 weeks [end of study] Scores are calculated from three 24-hour diet records, range from 0-100. Higher score reflects that higher alignment between one's diet and dietary recommendations from the Dietary Guidelines for Americans.
- Secondary Outcome Measures
Name Time Method Change in HbA1c Baseline, 12 weeks [end of study] HbA1c will be assessed through a blood draw.
Change in dermal carotenoids level Baseline, 12 weeks [end of study] Scores are measured using the Veggie Meter device, range from 0-800. Higher score acts as proxy for fruits and vegetables consumption.
Change in percent time sedentary Baseline, 12 weeks [end of study] Accelerometry data will be collected from wrist accelerometers worn by participants for 7 days. Percent time spent on sedentary will be calculated.
Change in percent time spent in light activity Baseline, 12 weeks [end of study] Accelerometry data will be collected from wrist accelerometers worn by participants for 7 days. Percent time spent in light activity will be calculated.
Change in percent time spent in moderate to vigorous activity Baseline, 12 weeks [end of study] Accelerometry data will be collected from wrist accelerometers worn by participants for 7 days. Percent time spent in moderate and vigorous activity will be calculated.
Change in body mass index Baseline, 12 weeks [end of study] Height will be measured using a stadiometer to the nearest decimal point in cm. Weight will be measured using a scale to the nearest decimal in kg. Body mass index will be calculated using kg/m\^2.
Change in high blood pressure status Baseline, 12 weeks [end of study] Blood pressure will be measured using blood pressure monitors. High blood pressure is considered as reading of \>=120/80.
Change in lipid profile Baseline, 12 weeks [end of study] Total, high-density, low-density cholesterol, and triglycerides will be assessed through a blood draws.
Change in body fat percentage Baseline, 12 weeks [end of study] Body fat percentage will be measured using a scale to the nearest decimal.
Change in waist circumference Baseline, 12 weeks [end of study] Waist circumference will be measured using a waist circumference tape to the nearest decimal in cm.
Trial Locations
- Locations (1)
Brownsville Neighborhood Health Action Center
🇺🇸Brooklyn, New York, United States
Brownsville Neighborhood Health Action Center🇺🇸Brooklyn, New York, United StatesElana MartinsContact718-312-6135emartin8@health.nyc.gov